Driver Assemblies, Drivers, Intraosseous Devices, and Methods for Determining Voltages and/or Impedances in Biological Material

ABSTRACT

Driver assemblies, drivers, drill bits, and methods for determining information (such as impedances, voltages, voltage differences, and changes in such information) about biological material during a medical procedure.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is continuation of U.S. patent application Ser. No.13/836,548, filed on Mar. 15, 2013, the contents of which areincorporated by reference in its entirety.

BACKGROUND 1. Field of the Invention

The present invention relates generally to driver assemblies, such asthose including a driver (e.g., manual or powered) and a drill bit, todrivers, to drill bits, and to methods of determining information whenpenetrating biological material, and more particularly, but not by wayof limitation, to driver assemblies that include drivers and drill bitsthat can be used to determine information (e.g., voltages, voltagedifferences, impedances, changes in voltage differences, changes inimpedances, and the like) about a target area in biological material(e.g., such as bone (and, more specifically, an intraosseous spacewithin bone) or cerebrospinal fluid), to drill bits usable with suchdrivers and driver assemblies, to such drivers, and to methods ofdetermining information, like penetrator (e.g., drill bit) positionwithin biological material and voltage differences and/or impedancesrelated to a target area (or a change in voltage differences and/orimpedances from a reference location, voltage difference, or impedancein a target area) within biological material.

SUMMARY

This disclosure includes embodiments of driver assemblies comprising adriver having at least one sensor and a penetrator that are configuredto permit the driver assembly to determine information about a targetarea within biological material, such as bone or cerebrospinal fluid.For example, embodiments of the present driver assemblies can beconfigured to display information relating to the voltage and/orelectrical impedance of biological material. As another example,embodiments of the present driver assemblies can be configured todisplay information relating to the position of a penetrator withinbiological material. This disclosure also includes embodiments ofpenetrators, such as drill bits, that may be coupled to drivers and usedto assist in determining such information. This disclosure also includesembodiments of methods of determining information (e.g., electricalimpedance, voltage, voltage differences, changes in impedances and/orvoltage differences, and the like) concerning a target area withinbiological material. Embodiments of the present driver assemblies, drillbits, and methods may be useful in procedures such as those thatestablish access to an intraosseous (TO) space, bone marrow biopsies,and craniotomies, to name a few.

Some embodiments of the present driver assemblies comprise a drivercomprising a controller; a motor coupled to a power source and furthercoupled to the controller such that the controller can affect themotor's operation; a drive shaft coupled to the motor such that themotor can move the drive shaft; a trigger coupled to the controller andconfigured to activate the motor; and a first electrode configured to becoupled to the controller; and a drill bit configured to be coupled tothe drive shaft and the controller, the drill bit comprising: an outersurface; a core disposed inside the outer surface; and an insulatordisposed between the core and the outer surface configured to preventelectrical communication between the core and the outer surface; wherethe outer surface, the insulator, and the core cooperate to form atleast one tip of the drill bit; and where the controller is configuredto determine at least one of a voltage difference between the core andthe first electrode and an impedance when the first electrode is coupledto the controller and at least when the driver assembly is used in amedical procedure. In some embodiments, a portion of the core is exposedat the tip of the drill bit.

Some embodiments of the present driver assemblies comprise a two-wireconfiguration. In some embodiments, the impedance is a normalizedimpedance when the controller determines an impedance. In someembodiments, the drill bit is configured to be coupled to the driveshaft by a commutating electrical connection. In some embodiments, thedrill bit is configured to be coupled to the drive shaft by a gear boxbearing, the gear box bearing configured to permit a commutatingelectrical connection between the drill bit and the drive shaft. In someembodiments, the controller is configured to pass an alternating currentto the core.

Some embodiments of the present driver assemblies comprise a secondelectrode configured to be coupled to the controller, the controllerconfigured to pass a current to the second electrode, when the first andsecond electrodes are coupled to the controller, to permit thecontroller to determine at least one of a voltage difference between thecore and the first electrode and an impedance at least when the driverassembly is used in a medical procedure. In some embodiments, at leastone of the first electrode and the second electrode comprises anadhesive configured to adhere at least one of the first electrode andthe second electrode to skin. In some embodiments, the assembliescomprise a patch connector configured to couple at least one of thefirst electrode and the second electrode to the controller. In someembodiments, the assembly comprises at least a three-wire configuration.In some embodiments, the controller is configured to pass an alternatingcurrent to the core and the second electrode. In some embodiments, thecontroller comprises a current source configured to pass an alternatingcurrent to the core and the second electrode. In some embodiments, thealternating current passed to the core and the second electrodeoriginates from the same current source. In some embodiments, thealternating current can comprise a frequency of 5 kHz to 150 kHz.

In some embodiments of the present driver assemblies, the controller isconfigured to determine a change in at least one of the impedance andthe voltage difference when the drill bit moves through biologicalmaterial. In some embodiments, the controller is configured to comparethe change in at least one of the impedance and the voltage differenceto a threshold. In some embodiments, the controller comprises athreshold detector configured to compare the change in at least one ofthe impedance and the voltage difference to the threshold. In someembodiments, the threshold is adjustable. In some embodiments, thecontroller is configured to deactivate the motor if the change in atleast one of the impedance and the voltage difference meets or exceedsthe threshold. In some embodiments, the controller is configured tochange a rotational speed of the motor if the change in at least one ofthe impedance and the voltage difference meets or exceeds the threshold.

In some embodiments of the present assemblies, the insulator comprises anon-conductive material. In some embodiments, the insulator comprisespolytetrafluoroethylene. In some embodiments, the insulator comprises athickness of 0.01 millimeters to 2 millimeters.

Some embodiments of the present assemblies comprise a display coupled tothe controller and configured to display information relating to atleast one of the impedance, the voltage between the core and the firstelectrode, and the change in at least one of the impedance and thevoltage difference. In some embodiments, the display comprises at leastone light emitting diode. In some embodiments, the display is configuredto indicate information about a position of the drill bit based on theimpedance, the voltage between the core and the first electrode, and thechange in at least one of the impedance and the voltage difference.

Some embodiments of the present assemblies comprise a drill bit couplerconfigured to be coupled to the drill bit and to the drive shaft. Insome embodiments, the drill bit coupler is insulated. In someembodiments, the drill bit coupler comprises an insulator.

Some embodiments of the present assemblies comprise at least one drillbit contact coupled to the drill bit and to the controller, the at leastone drill bit contact configured to permit electrical communicationbetween the controller and at least one of the core and the outersurface of the drill bit. In some embodiments, the drill bit contact iscoupled to the drill bit by a commutating electrical connection. In someembodiments, the drill bit contact is slidably coupled to the drill bit.In some embodiments, the controller is configured to receive informationfrom the core of the drill bit relating to at least one of current,voltage, impedance, and temperature. In some embodiments, the at leastone drill bit contact is further configured such that the controller canreceive information from the outer surface of the drill bit. In someembodiments, the information receivable from the outer surface relatesto at least one of current, voltage, impedance, and temperature. In someembodiments, the drill bit contact comprises a non-conductive coating.In some embodiments, the drill bit contact comprises a dielectric.

Some embodiments of the present assemblies comprise a reference buttoncoupled to the controller, the reference button being configured to setat least one of a reference impedance and a reference voltagedifference, and the controller being configured to determine a changefrom at least one of the reference impedance and the reference voltagedifference. In some embodiments, the reference button sets at least oneof the reference impedance and the reference voltage difference when thereference button is engaged. In some embodiments, the controller isconfigured to set at least one of a reference impedance and a referencevoltage difference automatically when the drill bit contacts apredetermined material within a target area. In some embodiments, thecontroller is configured to compare the change from at least one of thereference impedance and the reference voltage difference to a threshold.In some embodiments, the controller comprises a threshold detectorconfigured to compare the change from at least one of the referenceimpedance and the reference voltage difference to the threshold. In someembodiments, the threshold is adjustable. In some embodiments, thecontroller is configured such that if the change from at least one ofthe reference impedance and the reference voltage difference meets orexceeds the threshold, the controller will cause the display to indicateat least one of the impedance, the voltage between the core and thefirst electrode, and the change in at least one of the impedance and thevoltage difference. In some embodiments, the controller is configured todeactivate the motor if the change from at least one of the referenceimpedance and the reference voltage difference meets or exceeds thethreshold. In some embodiments, the controller is configured to change arotational speed of the motor if the change from at least one of thereference impedance and the reference voltage difference meets orexceeds the threshold.

In some embodiments, the present assemblies comprise an oscillatorconfigured to produce a signal in the current. In some embodiments, thesignal comprises a frequency of 10 kHz to 100 kHz. In some embodiments,the signal comprises a frequency of 50 kHz. In some embodiments, thecontroller further comprises a differential amplifier coupled to thedrill bit and to the first electrode, the differential amplifierconfigured to output a voltage difference between the drill bit and thefirst electrode. In some embodiments, the differential amplifiercomprises a high common mode rejection differential input amplifier. Insome embodiments, the controller further comprises a multiplier coupledto the oscillator and to the differential amplifier, the multiplierconfigured to multiply a signal received from the differential amplifierwith a signal received from the oscillator to down convert the voltagedifference to a baseband frequency. In some embodiments, the multiplieris configured to produce a direct voltage. In some embodiments, thecontroller further comprises a gain amplifier coupled to the multiplierand configured to increase a voltage of the baseband frequency producedby the multiplier. In some embodiments, the gain amplifier is configuredto increase the voltage of the baseband frequency by a factor of 1000.In some embodiments, the gain amplifier is configured to increase thevoltage of the baseband frequency by a factor of 100 to 10,000. In someembodiments, the controller further comprises a low pass filter coupledto the gain amplifier and configured to attenuate a signal output by thegain amplifier that has a higher frequency than a cutoff frequency.

Some embodiments of the present methods comprise placing a firstelectrode of a driver assembly in or on a non-target area; moving adrill bit of the driver assembly through biological material toward atarget area in biological material; and determining at least one of animpedance, a change in an impedance, a voltage difference, and a changein a voltage difference. In some embodiments, the methods comprisedisplaying a notification when at least one of the impedance, the changein an impedance, the voltage, and the change in a voltage differencemeets or exceeds a threshold. In some embodiments, the methods comprisechanging or stopping a rotational velocity of the drill bit when atleast one of the impedance, the change in an impedance, the voltage, andthe change in a voltage difference meets or exceeds a threshold. In someembodiments, the methods comprise placing a second electrode in or onthe non-target area to form at least a three-wire configuration with thedrill bit and the first electrode. In some embodiments, the methodscomprise displaying a notification when at least one of an impedance, achange in a impedance, a voltage, and a change in a voltage meets orexceeds a threshold. In some embodiments, the methods comprise changingor stopping a rotational velocity of the drill bit when at least one ofthe impedance, the change in an impedance, the voltage, and the changein a voltage meets or exceeds a threshold. In some embodiments, themethods comprise removing the drill bit from the target area to permitaccess to the target area.

Some embodiments of the present methods (e.g., of determining at leastone of a change in an impedance and a change in a voltage differenceacross biological material) comprise placing a first electrode of adriver assembly in or on a non-target area; moving a drill bit of thedriver assembly through biological material toward a target area inbiological material; setting at least one of a reference impedance and areference voltage difference; and determining a change from at least oneof the reference impedance and the reference voltage difference. In someembodiments, the methods comprise displaying a notification when thechange from at least one of the reference impedance and the referencevoltage difference meets or exceeds a threshold. In some embodiments,the methods comprise changing or stopping a rotational velocity of thedrill bit when the change from at least one of the reference impedanceand the reference voltage difference meets or exceeds a threshold. Insome embodiments, the methods comprise placing a second electrode in oron the non-target area to form at least a three-wire configuration. Insome embodiments, the methods comprise determining a change from atleast one of the reference impedance and the reference voltagedifference. In some embodiments, the methods comprise displaying anotification when the change from at least one of the referenceimpedance and the reference voltage difference meets or exceeds athreshold. In some embodiments, the methods comprise changing orstopping a rotational velocity when the change from at least one of thereference impedance and the reference voltage difference meets orexceeds a threshold. In some embodiments, the methods comprise removingthe drill bit from the target area to permit access to the target area.

Some embodiments of the present drivers comprise a controller configuredto determine at least one of an impedance and a voltage difference; amotor coupled to a power source and further coupled to the controllersuch that the controller can affect the motor's operation; a drive shaftcoupled to the motor such that the motor can move the drive shaft; atrigger coupled to the controller and configured to activate the motor;and a first electrode configured to be coupled to the controller; wherethe driver is configured to be coupled to an intraosseous (IO) deviceand used, with the IO device, to determine at least one of a change inan impedance and a change in a voltage difference across biologicalmaterial. In some embodiments, the driver comprises a two-wireconfiguration. In some embodiments, the driver is configured to generatean alternating current.

Some embodiments of the present drivers comprise a second electrodeconfigured to be coupled to the controller; where the controller canpass a current to the second electrode, when the first and secondelectrodes are coupled to the controller, to permit the controller todetermine at least one of an impedance and a voltage difference at leastwhen the driver is used with an IO device in a medical procedure. Insome embodiments, the drivers comprise at least a three-wireconfiguration. In some embodiments, the driver is configured to generatean alternating current. In some embodiments, the alternating current cancomprise a frequency of 5 kHz to 150 kHz.

In some embodiments of the present drivers, the controller is configuredto determine at least one of an impedance, a change in an impedance, avoltage difference, and a change in a voltage difference between whenthe first and second electrodes are coupled to the controller and thedriver is used with an IO device in a medical procedure. In someembodiments, the controller is configured to compare at least one of theimpedance, the change in an impedance, the voltage difference, and thechange in a voltage difference to a threshold. In some embodiments, thecontroller comprises a threshold detector configured to compare at leastone of the impedance, the change in an impedance, the voltagedifference, and the change in a voltage difference to the threshold. Insome embodiments, the threshold is adjustable. In some embodiments, thecontroller is configured to deactivate the motor if at least one of theimpedance, the change in an impedance, the voltage difference, and thechange in a voltage difference meets or exceeds the threshold. In someembodiments, the controller is configured to change a rotational speedof the motor if at least one of the impedance, the change in animpedance, the voltage difference, and the change in a voltagedifference meets or exceeds the threshold. In some embodiments, at leastone of the first electrode and the second electrode comprises anadhesive configured to adhere at least one of the first electrode andthe second electrode to skin. In some embodiments, a patch connectorconfigured to couple at least one of the first electrode and the secondelectrode to the controller.

Some embodiments of the present drivers comprise a display coupled tothe controller. In some embodiments, the display comprises at least onelight emitting diode.

Some embodiments of the present drivers comprise a drill bit couplerconfigured to be coupled to a drill bit and to the drive shaft. In someembodiments, the drill bit coupler is insulated. In some embodiments,the drill bit coupler comprises an insulator.

Some embodiments of the present drivers comprise a reference buttoncoupled to the controller, the reference button being configured to setat least one of a reference impedance and a reference voltagedifference, and the controller being configured to determine at leastone of a change in impedance from the reference impedance and a changein voltage difference from the reference voltage difference when thedriver is coupled to an IO device and used during a medical procedure.In some embodiments, the reference button sets at least one of thereference impedance and the reference voltage difference when thereference button is engaged. In some embodiments, the controller isconfigured to set at least one of the reference impedance and thereference voltage difference automatically when a condition is met. Insome embodiments, the controller is configured to compare at least oneof the change in impedance and the change in voltage difference to athreshold. In some embodiments, the controller comprises a thresholddetector configured to compare at least one of the change in impedanceand the change in voltage difference to the threshold. In someembodiments, the threshold is adjustable. In some embodiments, thecontroller is configured such that if at least one of the change inimpedance and the change in voltage difference meets or exceeds thethreshold, the controller will cause the display to change. In someembodiments, the controller is configured to deactivate the motor if atleast one of the change in impedance and the change in voltagedifference meets or exceeds the threshold. In some embodiments, thecontroller is configured to change a rotational speed of the motor if atleast one of the change in impedance and the change in voltagedifference meets or exceeds the threshold.

In some embodiments of the present drivers, the controller comprises anoscillator configured to produce a signal in the current. In someembodiments, the signal comprises a frequency of 10 kHz to 100 kHz. Insome embodiments, the signal comprises a frequency of 50 kHz. In someembodiments, the controller further comprises a differential amplifier.In some embodiments, the differential amplifier comprises a high commonmode rejection differential input amplifier. In some embodiments, thecontroller further comprises a multiplier coupled to the oscillator andto the differential amplifier, the multiplier configured to multiply asignal received from the differential amplifier with a signal receivedfrom the oscillator to down convert a voltage to a baseband frequency.In some embodiments, the multiplier is configured to produce a directvoltage. In some embodiments, the controller further comprises a gainamplifier coupled to the multiplier and configured to increase a voltageof the baseband frequency produced by the multiplier. In someembodiments, the gain amplifier is configured to increase the voltage ofthe baseband frequency by a factor of 1000. In some embodiments, thegain amplifier is configured to increase the voltage of the basebandfrequency by a factor of 100 to 10,000. In some embodiments, thecontroller further comprises a low pass filter coupled to the gainamplifier and configured to attenuate a signal output by the gainamplifier that has a higher frequency than a cutoff frequency.

Some embodiments of the present drill bits comprise an outer surface; acore disposed inside the outer surface; and an insulator disposedbetween the core and the outer surface configured to prevent electricalcommunication between the core and the outer surface, where the outersurface, the insulator, and the core cooperate to form at least one tipof the drill bit configured to penetrate bone, and where the drill bitis configured to be coupled to a driver and used to determine at leastone of a change in impedance and a change in voltage difference acrossbiological material during a medical procedure. In some embodiments, thedrill bit is configured to be coupled to a drive shaft of a driver by acommutating electrical connection. In some embodiments, the drill bit isconfigured to be coupled to the drive shaft by a gear box bearing, thegear box bearing configured to permit a commutating electricalconnection between the drill bit and a drive shaft of a driver. In someembodiments, the insulator comprises a non-conductive material. In someembodiments, the insulator comprises polytetrafluoroethylene. In someembodiments, the insulator comprises a thickness of 0.01 millimeters to2 millimeters. In some embodiments, a portion of the core is exposed atthe tip of the drill bit.

Any embodiment of any of the driver assemblies, drivers, drill bits, andmethods can consist of or consist essentially of—rather thancomprise/include/contain/have—any of the described elements, features,and/or steps. Thus, in any of the claims, the term “consisting of” or“consisting essentially of” can be substituted for any of the open-endedlinking verbs recited above, in order to change the scope of a givenclaim from what it would otherwise be using the open-ended linking verb.

The feature or features of one embodiment may be applied to otherembodiments, even though not described or illustrated, unless expresslyprohibited by this disclosure or the nature of the embodiments.

Details associated with the embodiments described above and others arepresented below.

BRIEF DESCRIPTION OF THE DRAWINGS

The following drawings illustrate by way of example and not limitation.For the sake of brevity and clarity, every feature of a given structureis not always labeled in every figure in which that structure appears.Identical reference numbers do not necessarily indicate an identicalstructure. Rather, the same reference number may be used to indicate asimilar feature or a feature with similar functionality, as maynon-identical reference numbers. The figures illustrate the describedelements using graphical symbols that will be understood by those ofordinary skill in the art. The embodiments of the present driverassemblies, drivers, drill bits, and their components shown in thefigures are drawn to scale for at least the embodiments shown.

FIG. 1A depicts a perspective view of a prior art intraosseous devicehaving a cannula and a stylet.

FIG. 1B depicts a perspective view of another prior art cannula.

FIGS. 1C and 1D depict perspective views of a prior art IO device havinga stylet disposed in the cannula of FIG. 1B.

FIG. 2 depicts a cross-sectional side view of a prior art driver thatmay be modified to have one of the present sensors and, thus, become oneof the present drivers.

FIG. 3 depicts a perspective view of the driver of FIG. 2 with a priorart coupler assembly and a prior art IO device.

FIG. 4 depicts the coupler assembly and IO device of FIG. 3.

FIG. 5 depicts portions of the driver of FIG. 2 and the coupler assemblyand a portion of the IO device of FIG. 3.

FIGS. 6A-6C depict various views of the coupler assembly of FIG. 3.

FIGS. 7A-7C depict various views of prior art kits.

FIG. 8A depicts a perspective view of one embodiment of the presentdriver assemblies that has a driver with a sensor and a drill bitcoupled to the driver, the driver assembly being configured to determineinformation about a target area, such as a location within biologicalmaterial.

FIG. 8B depicts a portion of the interior of the driver of the driverassembly of FIG. 8A.

FIG. 8C depicts an enlarged view of one embodiment of the present drillbits, which embodiment is shown in FIGS. 8A and 8B.

FIG. 8D depicts one embodiment of a circuit diagram for a controller ofthe driver assembly (and, more specifically, of the driver) of FIG. 8A.

FIG. 8E depicts another embodiment of a circuit diagram for a controllerof the driver assembly (and, more specifically, of the driver) of FIG.8A.

DESCRIPTION OF ILLUSTRATIVE EMBODIMENTS

The term “coupled” is defined as connected, although not necessarilydirectly, and not necessarily mechanically. Two items are “couplable” ifthey can be coupled to each other. Unless the context explicitlyrequires otherwise, items that are couplable are also decouplable, andvice-versa. One non-limiting way in which a first structure is couplableto a second structure is for the first structure to be configured to becoupled to the second structure. The terms “a” and “an” are defined asone or more unless this disclosure explicitly requires otherwise. Theterm “substantially” is defined as largely but not necessarily whollywhat is specified (and includes what is specified; e.g., substantially90 degrees includes 90 degrees and substantially parallel includesparallel), as understood by a person of ordinary skill in the art. Inany disclosed embodiment, the terms “substantially,” “approximately,”and “about” may be substituted with “within [a percentage] of” what isspecified, where the percentage includes 0.1, 1, 5, and 10 percent.

The terms “comprise” (and any form of comprise, such as “comprises” and“comprising”), “have” (and any form of have, such as “has” and“having”), “include” (and any form of include, such as “includes” and“including”) and “contain” (and any form of contain, such as “contains”and “containing”) are open-ended linking verbs. As a result, anapparatus or kit, or a component of an apparatus or kit, that“comprises,” “has,” “includes” or “contains” one or more elements orfeatures possesses those one or more elements or features, but is notlimited to possessing only those elements or features. Likewise, amethod that “comprises,” “has,” “includes” or “contains” one or moresteps possesses those one or more steps, but is not limited topossessing only those one or more steps. Additionally, terms such as“first” and “second” are used only to differentiate structures orfeatures, and not to limit the different structures or features to aparticular order.

The term “determine” (and any form of determine, such as “determines,”“determined,” and “determining”) is used broadly throughout thisdisclosure to include the receiving or gathering of information from anarea and any resulting calculations with and/or manipulations of suchinformation and should include terms (and derivatives of such terms)such as detecting, measuring, identifying, receiving, and similar terms.

Further, a system (such as one of the present driver assemblies), adevice (such as one of the present drivers or one of the present drillbits), or a component of a device (such as a controller or sensor of oneof the present drivers) that is configured in a certain way isconfigured in at least that way, but can also be configured in otherways than those specifically described.

Various types of coupler assemblies incorporating teachings of thepresent disclosure may be satisfactorily used to releasably engage oneend of a shaft extending from a driver with one end of an intraosseousdevice. For some embodiments, the powered driver may include adriveshaft having one end with a generally hexagonal cross sectionoperable to be releasably engaged with a latch mechanism disposed in oneend of a coupler assembly. For some embodiments, a coupler assemblyincorporating teachings of the present disclosure may be referred to asa “hands free” coupler, a quick disconnect or quick release couplerand/or port assembly.

Various types of coupler assemblies incorporating teachings of thepresent disclosure may be satisfactorily used to releasably engage oneend of a shaft extending from a driver with one end of an intraosseousdevice. For some embodiments, the powered driver may include adriveshaft having one end with a generally hexagonal cross sectionoperable to be releasably engaged with a latch mechanism disposed in oneend of a coupler assembly. For some embodiments, a coupler assemblyincorporating teachings of the present disclosure may be referred to asa “hands free” coupler, a quick disconnect or quick release couplerand/or port assembly.

Embodiments of the present powered drivers may be used to insert an IOdevice into a selected target area or target site in ten seconds orless. However, various teachings of the present disclosure are notlimited to use with powered drivers. Manual drivers and spring powereddrivers may also be used with IO devices (such as embodiments of thepresent drill bits) incorporating teachings of the present disclosure.

Examples of manual drivers are shown in co-pending patent applicationSer. No. 11/042,912 entitled Manual Intraosseous Device filed Jan. 25,2005 (published as US 2005/0165404). The term “fluid” may be used inthis application to include liquids such as, but not limited to, blood,water, saline solutions, IV solutions, plasma, or any mixture ofliquids, particulate matter, dissolved medication, and/or drugsassociated with biopsy or aspiration of bone marrow or communication offluids with bone marrow or other target sites. The term “fluid” may alsobe used in this patent application to include any body fluids and/orliquids containing particulate matter such as bone marrow and/or cellswhich may be withdrawn from a target area.

The terms “harvest” and “harvesting” may be used in this application toinclude bone and/or bone marrow biopsy and bone marrow aspiration. Boneand/or bone marrow biopsy (sometimes referred to as “needle biopsy”) maybe generally described as removing a relatively small piece or specimenof bone and/or bone marrow from a selected target area for biopsypurposes. Bone marrow aspiration (sometimes referred to as “bone marrowsampling”) may be generally described as removing larger quantities ofbone marrow from a selected target area. Relatively large quantities ofbone marrow may be used for diagnostic, transplantation, and/or researchpurposes. For example some stem cell research techniques may requirerelatively large quantities of bone marrow.

The term “insertion site” may be used in this application to describe alocation on a bone at which an intraosseous device may be inserted ordrilled into the bone and associated bone marrow. Insertion sites aregenerally covered by skin and soft tissue. The term “target area” refersto any location on or within biological material, such as the biologicalmaterial of a living human being.

The term “intraosseous (IO) device” may be used in this application toinclude, but is not limited to, any hollow needle, hollow drill bit,penetrator assembly, bone penetrator, catheter, cannula, trocar, stylet,inner penetrator, outer penetrator, IO needle, biopsy needle, aspirationneedle, IO needle set, biopsy needle set or aspiration needle setoperable to access or provide access to an intraosseous space orinterior portions of a bone. Such IO devices may be formed, at least inpart, from metal alloys such as 304 stainless steel and otherbiocompatible materials associated with needles and similar medicaldevices.

Embodiments of the present driver assemblies can be included in medicalprocedure trays such as those disclosed in International PatentApplication No. PCT/US2007/078207 (published as WO 2008/033874).

The devices and components shown in FIGS. 1A to 7C are prior art devicesand components, and the following description of them is provided togive the reader context for the types of devices and components that canbe used consistently with embodiments of the present driver assemblies,drivers, and methods.

Referring now to the drawings, and more particularly to FIG. 1A, showntherein and designated by the reference numeral 100 is one embodiment ofthe present intraosseous (IO) needle sets or aspiration needle sets.Aspiration needle set 100 comprises a hollow outer penetrator or cannula110 a, a corresponding inner penetrator or stylet (or trocar) 120, and ahub assembly 130 a. In the embodiment shown, first end 111 a of cannula110 a and first end 121 of stylet 120 are operable or configured topenetrate a bone and associated bone marrow. Various features of firstend 111 a of cannula 110 a and first end 121 of stylet 120 are shown inmore detail in. First end 101 of IO needle set 100 corresponds generallywith first end 111 a of cannula 110 a and first end 121 of stylet 120.

In the embodiment shown, cannula 110 a includes a plurality of markings104 disposed on exterior portions of the cannula. Markings 104 may bereferred to as “positioning marks” or “depth indicators,” and may beused to indicate the depth of penetration of needle set 100 into a boneand associated bone marrow. In some embodiments, cannula 110 a may havea length of approximately sixty (60) millimeters and/or a nominaloutside diameter of approximately 0.017 inches (e.g., correspondinggenerally to the dimensions of a sixteen (16) gauge needle). Cannula 110a and/or stylet 120 may be formed from stainless steel or other suitablebiocompatible materials. In some embodiments, markings 104 are spaced atone (1) centimeter intervals on exterior portions of cannula 110 a. Insome embodiments, one or more side ports 106 may be formed in exteriorportions of cannula 110 a spaced from first end 111 a.

Hub assembly 130 a may be configured and/or used to releasably disposestylet 120 within the longitudinal bore or lumen of cannula 110 a. Inthe embodiment shown, hub assembly 130 a includes a first hub 140 a anda second hub 150 a. A second end of cannula 110 a, opposite from firstend 111 a, may be securely engaged with hub 140 a. The second end ofstylet 120, opposite from first end 121, may be securely engaged withthe first end of hub 150 a. As shown in FIG. 1A, cannula 110 a mayextend longitudinally from first end 141 of hub 140 a. Stylet 120 mayalso extend from the first end of hub 150 a. The second end of hub 140 amay include a standard Luer lock fitting which may be releasably engagedwith a corresponding Luer lock fitting disposed within the first end ofsecond hub 150 a. The Luer lock fitting disposed on the second end ofhub 140 a may be in fluid communication with the bore or passage incannula 110 a, and may be operable to be releasably engaged with astandard syringe type fitting and/or a standard intravenous (IV)connection. In the embodiment shown, hub 150 a includes second end 152that generally corresponds with second end 132 of hub assembly 130 a andsecond end 102 of IO needle set 100. Hub 140 a may include first end 141which may generally correspond with first end 131 of hub assembly 130 a.Cannula 110 a may extend longitudinally from first end 141 of hub 140 aand first end 131 of hub assembly 130.

In the embodiment shown, the second end of a hub assembly may beoperable to be disposed within a receptacle formed in a couplerassembly, as described in more detail below. One feature of the presentdisclosure may include forming a hub assembly which may be releasablyengaged within a first receptacle disposed in a first end of a couplerassembly (e.g., receptacle 263 proximate first end 261 of elongated core260 as shown in FIGS. 6A-6B). The dimensions and configuration ofreceptacle 263 may be selected to prevent rotation of hub 150 a relativeto hub 140 a if hub assembly 130 a is disposed in receptacle 263 (e.g.,while inserting (rotating) an IO device into a bone and associated bonemarrow). A powered driver may be releasably engaged with a secondreceptacle disposed in a second end of the coupler assembly (e.g.,receptacle 264 proximate second end 262 of elongated core 260 as shownin FIGS. 6A-6B).

In the embodiment shown, intraosseous device or aspiration needle set100 a includes first end 151 of hub 150 a spaced from second end 142 ofhub 140 a. Portions of stylet 120 extending from first end 151 of hub150 a are shown slidably disposed within lumen or longitudinal bore 118of cannula 110 a. Hub assembly 130 a may include first end 131 which maycorrespond generally with first end 141 of hub 140 a. Hub assembly 130 amay also include second end 132 which may correspond generally withsecond end 152 of hub 150 a and second end 102 of hub assembly 130 a, asshown. Cannula 110 a may be attached to and extend from first end 141 ofhub 140 a. Second end 142 of hub 140 a may include one-half a typicalLuer lock connection or fitting operable to be releasably engaged withcorresponding portions of a Luer lock connection or fitting disposed infirst end 151 of second hub 150 a. For embodiments such as the one shownin FIG. 1A, first end 131 of hub assembly 130 a may correspond withfirst end 141 of first hub 140 a. Second end 152 of second hub 150 a maycorrespond with second end 132 of hub assembly 130 a and second end 102of aspiration needle set 100 a.

At least one portion of hub assembly 130 a may have a generallyhexagonal cross section operable to be received within the generallyhexagonal cross section of receptacle 263 disposed proximate first end251 of coupler assembly 250, as shown in FIGS. 6A-6B. For someembodiments, portions of first hub 140 a disposed adjacent to reducedoutside diameter portion 143 may have generally hexagonal crosssections, as shown in FIG. 1A. In other embodiments, various crosssections other than hexagonal may be satisfactorily used to releasablyengage a powered driver with one end of a coupler assembly and anintraosseous device with an opposite end of the coupler assembly.Aspiration needle sets may include a stylet, stylet or penetrator incombination with an associated cannula, catheter or outer penetrator.However, biopsy needles formed in accordance with teachings of thepresent disclosure may or may not include a stylet, stylet or innerpenetrator.

Hub 140 a may include second end 142 with opening 144 formed therein. Apassageway may extend from second end 142 towards first end 141 of hub140 a, as illustrated in FIGS. 6A-6B. A passageway may be operable tocommunicate fluids with lumen 118 of cannula 100 a. Second end 142 ofhub 140 may include various features of a conventional Luer lockconnection or fitting, including threads 148, and corresponding threads158 may be formed within first end 151 of hub 150 a, as shown in FIGS.6A-6B.

For some applications hub 140 a and hub 150 a may, for example, beformed using injection molding techniques. For such embodiments hub 140a may include reduced outside diameter portion 143 disposed betweenfirst end 141 and second end 142. In a similar manner a plurality ofvoid spaces or cutouts 153 may be formed in hub 150 a adjacent to andextending from second end 152 in the direction of first end 151. Theconfiguration and dimensions of reduced diameter portion 143 and/orcutouts 153 may be varied to optimize associated injection moldingtechniques and at the same time provide required configurations,dimensions and material strength to allow associated hub assembly 130 ato function as described in this disclosure.

In some embodiments, tip 123 of stylet 120 may be disposed relativelyclose to a tip of cannula 110 a. For some applications, first end 121 ofstylet 120 and first end 111 a of cannula 110 a may be ground at thesame time to form adjacent cutting surfaces. Grinding ends 111 a and 121at the same time may result in forming a single cutting unit to formgenerally matching cutting edges. Other types of cutting surfaces formedin accordance with teachings of the present disclosure may be discussedlater (e.g., as described with reference to FIGS. 1B-1D).

FIGS. 1B-1D show a second example of cutting surfaces and tips which maybe formed adjacent to the ends of a cannula and/or an associated styletin the present embodiments. In the embodiment shown, outer penetrator orcannula 110 g may include first end 111 g having a plurality of cuttingsurfaces 114 g formed adjacent to opening 116 in first end 111 g.Opening 116 may communicate with and form a portion of an associatedlongitudinal bore or lumen 118. For some applications cutting surfaces114 g may be formed using electrical discharge machining (EDM)techniques or otherwise, as described in WO 2008/033874. In theembodiment shown, first end 111 g has a generally tapered configurationor reduced outside diameter as compared with other portions of cannula110 g In other embodiments, first end 111 g has an outside diameter thatis equal to the outside diameter of other portions of cannula 110 g(e.g., cannula 110 g can have a constant outside diameter along theentire length of the cannula). Cutting surfaces 114 g may, for example,be formed using machine grinding techniques. In some embodiments, suchas the one shown, end 111 g of cannula 110 g may include six groundcutting surfaces 114 g with respective crowns 115 therebetween. Forminga biopsy needle set and/or biopsy needle with tapered end 111 g and aplurality of cutting surfaces 114 g and crowns 115 may provide improveddrilling performance (e.g., relative to others configurations) when theresulting biopsy needle set and/or biopsy needle is used with a powereddriver in accordance with teachings of the present disclosure. For someapplications, a helical groove 117 may be formed within longitudinalbore 118 proximate opening 116. Helical groove 117 may assist withretaining a biopsy specimen or a bone marrow specimen withinlongitudinal bore 118. For example, a single thread may be disposedwithin the longitudinal bore or lumen of the cannula such that thehelical groove 117 is defined between turns of the thread. Varioustechniques and procedures may be satisfactorily used to place the singlethread or otherwise form the helical groove, as described WO2008/033874.

As shown in FIG. 1C, a biopsy needle set 100 g may include cannula orouter penetrator 110 g with stylet or inner penetrator 120 g slidablydisposed therein. The proximal ends of cannula 110 g and stylet 120 gmay be similar to those of cannula 110 a and stylet 120 depicted in FIG.1A (e.g., may include hubs 140 a and 150 a, respectively). For someapplications first end 101 of biopsy needle set 100 g may minimizedamage to skin and soft body tissue at an insertion site. For someapplications inner penetrator or stylet 120 g may include first end 121having a plurality of cutting surfaces 125 and 126 formed on exteriorportions thereof extending from associated tip 123 towards second end ofstylet or inner penetrator 120 g. For some applications one or morecutting surfaces 125 may be formed having length 127 extending from tip123 to associated cutting surfaces 114 g in associated cannula 110 g.One or more cutting surfaces 126 may be formed adjacent to each cuttingsurface 125 with second length 128. First length 127 may be greater thansecond length 128. As shown, lengths 127 and 128 are measured parallelto the central longitudinal axis of stylet 120 g. The ratio of firstlength 127 and second length 128 may be varied in accordance withteachings of the present disclosure to provide optimum performance forpenetrating a selected bone and associated bone marrow. Additionaldetails of some embodiments of first end 101 are described in WO2008/033874.

FIG. 2 depicts a cross-sectional view of one embodiment of a driver thatcan be used as an example for an embodiment of the present drivers withsensors and methods and kits comprising such drivers. In the embodimentshown, powered driver 200 may be used to insert intraosseous devicesinto a bone and associated bone marrow. Powered driver 200 may includehousing 210 having a general configuration similar to a small pistoldefined in part by handle 214. Various components associated withpowered driver 200 may be disposed within housing 210 (e.g., handle214). For example a power source such as battery pack 216 may bedisposed within handle 214. Housing 210 may be formed from relativelystrong, heavy duty polymeric materials such as polycarbonate or othersatisfactory materials. For some applications housing 210 may be formedin two halves (not expressly shown) which may be joined together with afluid tight seal to protect various components of powered driver 200disposed therein.

Motor 218 and gear assembly 220 may be disposed within portions ofhousing 210 adjacent to handle 214. Motor 218 and gear assembly 220 maybe generally aligned with each other. Motor 218 may be rotatably engagedwith one end of gear assembly 220. Drive shaft 222 may be rotatablyengaged with and extend from another end of gear assembly 220 oppositefrom motor 218. For some applications both motor 218 and gear assembly220 may have generally cylindrical configurations. Distal end or firstend 211 of housing 210 may include an opening with portions of driveshaft 222 extending through the opening, as shown. For someapplications, end 224 or the portion of drive shaft 222 extending fromfirst end 211 of housing 210 may have a generally hexagonal crosssection with surfaces 226 disposed thereon. Receptacle 263 disposed insecond end 252 of coupler assembly 250 may have a matching generallyhexagonal cross section, as shown in FIGS. 6A-6C.

Surfaces 226 may extend generally parallel with each other and parallelwith respect to a longitudinal axis or rotational axis of drive shaft222. One or more tapered surfaces 228 may also be formed on end 224 toassist with releasably engaging powered driver 200 with coupler assembly250. Embodiments of powered driver 200 include speed reduction ratios,for example, of between 60:1 and 80:1, resulting in drive shaft RPMsthat are reduced relative to motor RPMs. Coupler assemblies havingcorresponding openings or receptacles may be releasably engaged with end224 extending from first end 211 of powered driver 200. For example, end224 extending from first end 211 of housing 210 may be releasablyengaged with receptacle 264 disposed proximate second end 252 of couplerassembly 250, as shown in FIGS. 6A-6B.

For some applications thrust bearing 241 may be disposed between firstend or distal end 211 of housing 210 and adjacent portions of gearassembly 220. Thrust bearing 242 may be disposed between second end orproximal end 212 of housing 210 and adjacent portions of motor 218.Thrust bearings 241 and 242 may limit longitudinal movement of motor218, gear assembly 220 and drive shaft 222 within associated portions ofhousing 210. Trigger assembly 244 may also be disposed within housing210 proximate handle 214. Trigger assembly 244 may include trigger orcontact switch 246. Motor 218 may be energized and deenergized byalternately depressing and releasing trigger 246. Electrical circuitboard 247 may also be disposed within housing 210. Electrical circuitboard 247 may be electrically coupled with trigger assembly 244, motor218, power supply 216 and indicator light 248. For some applicationsindicator light 248 may be a light emitting diode (LED) or a small moreconventional light bulb. For some applications indicator light 248 maybe activated when ninety percent (90%) of electrical storage capacity ofbattery pack 216 has been used. The configuration and dimensions of anintraosseous device formed in accordance with teachings of the presentdisclosure may vary depending upon respective intended applications foreach intraosseous device. For example the length of a biopsy needleformed in accordance with teachings of the present disclosure may varyfrom approximately five (5) millimeters to thirty (30) millimeters.

Coupler assemblies incorporating teachings of the present disclosure mayfunction as “quick release mechanisms” operable to engage and disengagean IO device from a powered driver (e.g., a driver disposed within aflexible containment bag or sterile sleeve). Such coupler assemblies mayallow rotation of an IO device (e.g., biopsy needle or needle set)without damage to the flexible containment bag or sterile sleeve. Oneend of the coupler assembly may be operable to form a fluid seal orfluid barrier with adjacent portions of the containment bag or sterilesleeve. A coupler assembly incorporating teachings of the presentdisclosure may also be described as a port assembly attached to acontainment bag. Such port assemblies may allow easy engagement ordisengagement of a powered driver from an IO device and at the same timeallow the powered driver to “power in and power out” an IO device froman insertion site.

FIGS. 3-6C depict an example of a coupler assembly 250 suitable for someembodiments of the present assemblies and kits. FIGS. 3-5 areperspective views showing various views of powered driver 200, couplerassembly 250 a, and intraosseous device 100 b that is substantiallysimilar to device 100 a with the exception that device 100 b does notinclude markings 104. Coupler assembly 250 a includes a first end 251operable to be releasably engaged with one end of an intraosseous devicesuch as, but not limited to, second end 102 of biopsy needle set 100 b.Coupler assembly 250 a also includes a second end 252 operable to bereleasably engaged with a portion of a drive shaft extending from apowered driver, such as, but not limited to, end 224 of drive shaft 222extending from first end 211 of housing 210 of powered driver 200.Though not depicted here, second end 252 of coupler assembly 250 may besecurely engaged with an opening in a containment bag or sterile sleeve,as described in WO 2008/033874.

Coupler assemblies incorporating various teachings of the presentdisclosure may be placed in a medical procedure tray or kit with one enddown and an opposite end looking up to allow “hands free” releasableengagement with a powered driver or a manual driver. For example,coupler assembly 250 a may be disposed in medical procedure tray withfirst end 251 facing downward and second end 252 facing up such that end224 of drive shaft 222 (of driver 200) may be inserted into andreleasably engaged with second end 252 of coupler assembly 250 withoutrequiring an operator or user to physically contact or manipulate anyportion of coupler assembly 250 a. As described below, coupler 250 a mayinclude a “hands free” latching mechanism.

In the embodiment shown, coupler assembly 250 a may include elongatedcore 260 with housing assembly 270 slidably disposed on exteriorportions of elongated core 260. Housing assembly 270/270 a may includefirst end 271 and second end 272 which may be generally aligned withrespective first end 261 and respective second end 262 of elongated core260. For some applications, elongated core 260 may have a generallycylindrical configuration defined in first exterior portion 260 a andsecond exterior portion 260 b with various shoulders and/or recessesformed thereon. For some embodiments first exterior portion 260 a mayhave a larger diameter than second exterior portion 260 b. Housingassembly 270 may be described as having a generally hollow, cylindricalconfiguration defined in part by first housing segment 280 and secondhousing segment 290. The first end of housing segment 280 may generallycorrespond with first end 271 of housing assembly 270. The second end ofsecond housing segment 290 may generally correspond with second end 272of housing assembly 270. First end 291 of second housing segment 290 maybe described as having a generally cylindrical configuration with anoutside diameter smaller than the adjacent inside diameter of second end282 of first housing segment 280. Second housing segment 290 may slidelongitudinally from a first position (FIG. 6A) to a second position(FIG. 6B) within second end 282 of first housing segment 280 to releaseone end of a drive shaft engaged with second end 252 of coupler assembly250.

A biasing mechanism such as coiled spring 274 may be disposed aroundexterior portion 260 a of generally elongated core 260. First end 275 ofcoiled spring 274 may contact annular shoulder 284 formed on interiorportions of first housing segment 280. Second end 276 of coiled spring274 may contact annular shoulder 278 disposed proximate first end 291 ofsecond housing segment 290. Coil spring 274, annular shoulder 284 andannular shoulder 278 may cooperate with each other to generally maintainfirst housing segment 280 and second housing segment 290 in a firstextended position relative to each other. Other biasing mechanisms suchas, but not limited to, leaf springs and bellows (not expressly shown)may also be disposed between annular shoulder 284 and annular shoulder278. Annular shoulder 278, associated with second end 276 of coiledspring 274, may extend radially outward from generally cylindrical ring277. Generally cylindrical ring 277 may be slidably and rotatablydisposed on exterior portion 260 a of elongated core 260. Annularshoulder 279 may be disposed on interior portions of generallycylindrical ring 277 and may extend radially inward toward adjacentportions of elongated core 260. Annular shoulder 268 may be formed onexterior portion 260 a of elongated core 260 intermediate first end 261and second end 262. The configuration and dimensions of annular shoulder268 and annular shoulder 279 are selected to be compatible with eachother such that engagement between annular shoulder 279 of generallycylindrical ring 277 with annular shoulder 268 of elongated core 260 maylimit movement of second housing segment 290 longitudinally in thedirection of second end 262 of elongated core 260.

For some applications a plurality of flexible collets or fingers 477 mayextend from generally cylindrical ring 277 opposite from annularshoulder 278. Respective collet heads 478 may be formed on the end ofeach collet 477 opposite from annular shoulder 278. The dimensions andconfiguration of collet heads 478 may be selected to be received withinrespective slots or openings 297 formed in second housing 290. Duringmanufacture of coupler assembly 250 a, each collet head 478 may bedisposed within respective slot or opening 297 to securely engagegenerally cylindrical ring 277 and annular shoulder 278 proximate firstend 291 of second housing segment 290. As a result, second housingsegment 290 and annular shoulder 278 may generally move as a single unitrelative to elongated core 260 and first housing segment 280. Duringdisengagement of an intraosseous device from first end 251 of couplerassembly 250 a, first housing segment 280 may move or slidelongitudinally toward second housing segment 290. In a similar manner,second housing segment 290 may move or slide longitudinally toward firsthousing segment 280 during disengagement of a powered driver from secondend 252 of coupler assembly 250 a.

Annular shoulder 267 may be formed on exterior portions of elongatedcore 260 proximate first end 261. Annular shoulder 267 may engageportions of first end 271 of housing 270 to limit longitudinal movementof first housing segment 280 during longitudinal movement of secondhousing segment 290 towards first end 261 of elongated core 260 duringdisengagement of a powered driver from second end 252 of couplerassembly 250 a. As previously noted, annular shoulder 268 may be formedon exterior portions of elongated core 260 between first end 261 andsecond end 262. Engagement between annular shoulder 268 and annularshoulder 279 of generally cylindrical ring 277 may limit movement ofsecond housing segment 290 toward second end 262 of elongated core 260.Contact between spring 274 and annular shoulder 278 and annular shoulder284 of first housing segment 280 may limit the longitudinal movement offirst housing segment 280 in the direction of second end 262 ofelongated core 260 during disengagement of an intraosseous device fromfirst end 251 of coupler assembly 250 a.

Generally cylindrical ring 277 and attached annular shoulder 279 mayslide longitudinally on exterior portions of annular core 260 betweenannual shoulder 268 and annular shoulder 267. First housing segment 280may move longitudinally toward second end 262 of elongated core 260 torelease one end of intraosseous device from engagement with first end251 of coupler assembly 250 a. In a similar manner, second housingsegment 290 may move longitudinally toward first end 261 of elongatedcore 260 to release one end of a drive shaft extending from a powereddriver engaged with second end 252 of coupler assembly 250 a. A widevariety of latches and latch mechanisms may be satisfactorily used toreleasably engage one end of an intraosseous device within a first endof a coupler assembly incorporating teachings of the present disclosure.In a similar manner, a wide variety of latches and latch mechanisms maybe satisfactorily used to releasably engage one end of a drive shaftextending from a powered driver or manual driver within a second end ofthe coupler assembly incorporating teachings of the present disclosure.

For embodiments represented by coupler assembly 250 a, first latch 410may be disposed on exterior portions of elongated core 260 proximatereceptacle 263 adjacent to first end 261 to releasably engage one end ofan IO device such as second end 102 of biopsy needle set 100 b withinreceptacle 263 of coupler assembly 250 a. Second latch mechanism 420 maybe disposed on exterior portions of elongated core 260 proximatereceptacle 264 adjacent to second end 262 to releasably engage one endof a drive shaft with second end 252 of coupler assembly 250 a. Secondlatch 420 may be used to releasably engage one portion of a drive shaftsuch as end 224 of drive shaft 222 extending from powered driver 200within second end 252 of coupler assembly 250 a. Latch 410 mayreleasably engage an intraosseous device with first end 251 of couplerassembly 250 a and substantially the same latch 420 may releasablyengage a powered driver with second end 252 of coupler assembly 250 a.

For some applications, latches 410 and 420 may have similarconfigurations such as a general “omega” shape (e.g., latch 420).However, latch 410 may have larger dimensions corresponding generallywith exterior portion 260 a of elongated core 260. Latch 420 may havesmaller dimensions corresponding generally with exterior portion 260 bof elongated core 260. Various features of the present disclosure may bedescribed with respect to latch mechanism 420 along with adjacentportions of second housing segment 290 and exterior portion 260 b ofelongated core 260. Respective detents 421 and 422 may be formed onopposite ends of generally omega shaped latch 420. In a similar manner,respective detents (not expressly shown) may be formed on the ends ofgenerally omega shaped latch 410. The configuration and dimensions ofdetents 421 and 422 may be compatible with placing each detent 421 and422 in a respective slot or opening extending between exterior portion260 b of elongated core 260 to interior portions of receptacle 264disposed proximate second end 252 of coupler assembly 250 a. Latch 420may have a first position in which portions of detents 421 and 422 mayextend through the respective slots. The dimensions and configuration ofdetent 421 and 422 may be operable to be securely engaged with annulargroove 402 formed in end 224 of powered driver 200. In a similar manner,respective detents on associated latch 410 may be releasably engagedwith annular groove 401 disposed in second end 102 of biopsy needle 100b. For some applications, a plurality of tapered surfaces 403 may beformed on exterior portions of hub 140 a proximate first end 142 toradially expand detent mechanisms associated with omega shaped latch 410radially outward while inserting second end 102 of biopsy needle 100 binto first end 251 of coupler assembly 250 a. The detent mechanism may“snap” into annular groove 401 when aligned therewith. In a similarmanner, a plurality of tapered surfaces 228 may be formed on exteriorportions of end 224 of drive shaft 222 extending from powered driver 200to radially expand detent mechanisms 421 and 422 radially outward duringthe insertion of end 224 of powered driver 200 into second end 252 ofcoupler assembly 250 a. Detent mechanisms 421 and 422 will “snap” intoannular groove 402 when aligned therewith.

Engagement between detent mechanisms associated with latch 410 withannular groove 401 of hub assembly 130 a will generally retain secondend 102 of biopsy needle 100 b securely engaged with first end 251 ofcoupler assembly 250 a. This engagement may allow powered driver 200 torotate or spin cannula or biopsy needle 110 b while withdrawing cannulaor biopsy needle 110 b from an insertion site. In a similar manner,engagement between detent mechanisms 421 and 422 of omega shaped latch420 and annular groove 402 of end 224 of powered driver 200 willgenerally retain second end 252 of coupler assembly 250 a engaged withpowered driver 100 during withdrawal of cannula 110 b from an insertionsite.

Biopsy needle set 100 b may be released from first end 251 of couplerassembly 250 a by sliding first housing segment 280 longitudinallytoward second end 262 of elongated core 260. Such movement of firsthousing segment 280 will result in interior tapered surface 286contacting exterior portions of omega shaped latch 410 and compressingomega shaped latch 410 to radially expand associated detent mechanisms(not expressly shown) from engagement with annular groove 401 of hubassembly 130 a. As a result, biopsy needle set 100 b may be easilywithdrawn from first end 251 of coupler assembly 250 a. In a similarmanner, longitudinal movement of second housing segment 290 toward firstend 251 of coupler assembly 250 a will result in interior taperedsurface 296 contacting exterior portions of omega shaped latch 420 tocompress generally omega shaped latch 420 and withdraw or retract detentmechanisms 421 and 422 from engagement with annular groove 402 of end224. As a result, powered driver 200 and second end 222 of couplerassembly 250 a may be easily disconnected from each other.

Flange 254 may be generally described as having an enlarged funnelshaped or bell shaped configuration. The dimensions and configuration offlange 254 may be selected to be compatible with end 211 of powereddriver 200. As previously noted, coupler assembly 250 a may be securelyengaged with an opening formed in a containment bag or sterile sleeve inaccordance with teachings of the present disclosure. For embodimentssuch as the one shown, end 272 of housing 270 of coupler assembly 250 amay include annular ring 370 operable to be securely engaged withadjacent portions of flange 254. The outside diameter of annular ring370 may generally correspond with the outside diameter of adjacentportions of flange 254. The inside diameter of annular ring 370 may alsogenerally correspond with the inside diameter of adjacent portions offlange 254. For some embodiments a plurality of posts 372 and generallyV shaped grooves 374 may be alternatingly disposed on the extreme end offlange 254. Annular ring 370 may include a plurality of holes 371 sizedto received respective posts 372 therein. Annular ring 370 may alsoinclude a plurality of generally V shaped projections 376 sized to bereceived within respective generally V shaped grooves 374 formed inadjacent portions of flange 254. For embodiments such as the one shown,portions of a containment bag (e.g., around an opening) may be disposedbetween annular ring 370 and adjacent portions of flange 254. Forexample, post 372 may be inserted through a corresponding hole in acontainment bag adjacent to the perimeter of an opening in thecontainment bag. Holes 371 in annular ring 370 may be aligned withrespective posts 372. Other portions of a containment bag (e.g.,adjacent to an opening) may be trapped between respective V shapedprojections 376 and V shaped grooves 374. Various welding techniquesincluding, but not limited to, laser welding may be applied to posts 372to bond annular ring 370 with adjacent portions of flange 354. As aresult, a perimeter of a containment bag around an opening in thecontainment bag may be securely engaged with second end 252 of couplerassembly 250 a.

FIGS. 7A-7C show some examples of medical procedure trays and/or kitswhich may contain one or more intraosseous devices and/or othercomponents incorporating teachings of the present disclosure. Forexample, medical procedure tray 20 a as shown in FIG. 7A may includeintraosseous needle set or aspiration needle set 100 incorporatingvarious teachings of the present disclosure. Medical procedure tray 20 bas shown in FIG. 7B may include intraosseous needle set or biopsy needleset 100 b, ejector 90, funnel 80 and/or containment bag or sterilesleeve 170. Medical procedure tray 20 c as shown in FIG. 7C may alsoinclude various 10 devices and other components incorporating teachingsof the present disclosure including, but not limited to, biopsy needleset 100 b, coupler assembly 250, containment bag 170, ejector 90 and/orfunnel 80 a.

Medical procedure trays and/or kits formed in accordance with teachingsof the present disclosure may provide a support or base for variouscomponents such as a coupler assembly, funnel, and/or sharps protectorto allow an operator or user to perform various functions withoutrequiring that the operator or user hold or manipulate the respectivecomponent. For example, medical procedure tray 20 c as shown in FIG. 7Cmay position and support coupler assembly 250 such that one end of apowered driver may be inserted (pushed) into releasable engagement withsecond end 252 of coupler assembly 250. The powered driver may then beused to withdraw coupler assembly 250 from medical procedure tray 20 cwithout requiring an operator or user to directly hold or manipulatecoupler assembly 250.

Medical procedure trays 20 a, 20 b and/or 20 c may also contain a widevariety of other components including, but not limited to, one or moresharps protectors 64 as shown in FIGS. 7A and 7B. Sharps protectors 64may include hard foam or claylike material 66 disposed therein.Intraosseous devices such as aspiration needle sets and biopsy needlesets typically have respective sharp tips and/or cutting surfacesoperable to penetrate skin, soft tissue and bone. The sharp tips and/orcutting surfaces of such intraosseous devices may be inserted into hardfoam or claylike material 66 after completion of a medical procedureusing the respective intraosseous device.

FIG. 7C shows one procedure for placing a powered driver within acontainment bag incorporating teachings of the present disclosure.Containment bag 170 may be formed from generally flexible, fluidimpervious material which may also be sterilized using conventionalsterilization techniques. Containment bag 170 may be used to prevent anon-sterile powered driver from contaminating a sterile intraosseousdevice and/or an injection site, particularly during a bone marrowbiopsy procedure or a bone marrow aspiration procedure. Containment bag170 may be operable to form a fluid barrier with adjacent portions ofhousing assembly 270. At the same time, coupler assembly 250 may allowpowered driver to rotate an intraosseous device releasably engaged withfirst end 251 of coupler assembly 250 without damage to containment bag170.

Referring now to FIGS. 8A-8B, designated by the reference numeral 510 isone embodiment of the present driver assemblies. Driver assembly 510comprises driver 512 configured, for example, to rotate and/or moveintraosseous needle sets and/or drill bits to penetrate a target area.Driver assembly 510 is configured to determine (and driver 512 isconfigured for use in determining), for example, a voltage and/or avoltage difference between a target area and another (e.g., non-target)area, an impedance at a target area, and/or determining a change in atleast one of a voltage difference and/or an impedance. Embodiments ofdriver assembly 510 can comprise—but are not required to comprise—one ormore components and/or characteristics of any of the other drivers andintraosseous devices described and depicted throughout this disclosure(e.g., FIG. 2).

In the embodiment shown, driver 512 comprises housing 514, which has aconfiguration similar to a pistol (e.g., having a barrel-shape, ahandle, etc.). Various components associated with driver assembly 510,and more specifically with driver 512, are disposed within housing 514.Housing 514 may comprise substantially rigid polymeric material (e.g., apolycarbonate) and, in some embodiments, housing 514 can comprise asingle piece of material; in other embodiments, housing 514 can comprisemore than one piece of material (e.g., two halves coupled with a fluidtight seal). In the embodiment shown, housing 514 includes handle 518,which can have various configurations, including, for example, beingconfigured to be gripped by a user.

In the embodiment shown, driver 510, and more specifically driver 512,includes controller 522. Controller 522 can be configured to controlvarious components (e.g., a motor) of driver 512. Controller 522 canalso be configured to determine various characteristics (e.g., voltage,voltage differences, impedances, changes in at least one of voltagedifferences and impedances, and the like) of a target and/or another(e.g., a non-target) area. In the embodiment shown, driver 512 alsoincludes motor 526 coupled to power source 530 (e.g., a battery) andfurther coupled to controller 522. Controller 522 can be configured, forexample, to activate and/or deactivate motor 526 (based on, for example,user input, position of an intraosseous device (such as a drill bit)within a target area, an impedance, a voltage difference, or a change inat least one of an impedance and a voltage difference).

In the embodiment shown, driver 512 also includes drive shaft 534coupled to motor 526 such that motor 526 can rotate drive shaft 534.Drive shaft 534 can be configured similarly to other embodiments ofdrive shafts described and depicted throughout this disclosure (e.g.,FIG. 2). In some embodiments, drive shaft 534 can be coupled to motor526 by a gear assembly (e.g., gear assembly 220, in previously describedembodiments). In some embodiments, drive shaft 534 can have asubstantially hexagonal cross-section (e.g., corresponding to thecoupler assembly depicted in FIG. 6C). In other embodiments, drive shaft534 can have a cross-section with any shape configured to be coupled toa corresponding intraosseous device, such as a drill bit or a needleset.

In the embodiment shown, driver 512 includes trigger 538, which can becoupled to motor 526 and/or controller 522. Trigger 538 can be engagedto activate (and/or deactivate, in some embodiments) motor 526 to permitmotor 526 to rotate drive shaft 534 and any coupled intraosseous device.

In the embodiment shown, driver assembly 510 also includes drill bit 542(FIG. 8C), which is configured to be coupled to driver 512. In thisdisclosure, a first structure that is configured to be coupled to asecond structure can be not coupled to the second structure or it can becoupled to the second structure (and, in either case, is stillconfigured to be coupled to the second structure). Drill bit 542includes an exposed portion (an exposed distal portion, in thisembodiment) having a first end 546 and second end 550. Drill bit 542 canbe—but is not required to be—coupled to drive shaft 534 similarly to theways in which other intraosseous devices (e.g., needle sets) discussedthroughout this disclosure can be coupled to a drive shaft (e.g., via acoupler assembly having a hub). In the embodiment shown, for example,driver assembly 510 comprises drill bit coupler 554, which can be partof drill bit 542 when an operator first obtains the drill bit for use,or which can be an element separate from and couplable to drill bit 542when an operator first obtains the drill bit for use (such as eitherbeing a structure that can be coupled to driver 512 or that is coupledto driver 512 when an operator first obtains the driver for use). Drillbit coupler 554 includes first end 558 configured to be coupled (e.g.,detachably) to second end 550 of drill bit 542. Drill bit coupler 554also includes second end 562 configured to be coupled (e.g., detachably)to drive shaft 534 (e.g., by a female hexagonal configurationcorresponding to a male hexagonal configuration of drive shaft 534).Drill bit coupler 554 can be insulated (such as, for example, bycomprising an insulator (e.g., polytetrafluoroethylene)) tosubstantially prevent heat and/or electricity from drill bit 542 frompassing beyond drill bit coupler 554.

In the embodiment shown, second end 550 of drill bit 542 is furtherconfigured to be coupled to controller 522 by a commutating electricalconnection (e.g., via a gear box bearing) to permit electricalcommunication between drill bit 542 and controller 522. For example, inthe embodiment shown, driver 512 has at least one drill bit contact 566coupled (e.g., slidably) to drill bit 542 and to controller 522. Drillbit contact 566 is configured to provide a commutating electricalconnection between drill bit 542 and controller 522. Drill bit contact566 can comprise a non-conductive coating (e.g., a dielectric, such aspolytetrafluoroethylene) configured to substantially prevent electricityfrom drill bit 542 from passing beyond drill bit contact 566.

In the embodiment shown, drill bit 542 is configured to penetrate atarget area (e.g., target area 570). Drill bit 542 includes outersurface 574 extending from second end 550 to first end 546 of theexposed portion of drill bit 542. Outer surface 574 has groove(s) 578(e.g., thread(s)) that help enable drill bit 542 to penetrate biologicalmaterial (e.g., bone) to reach a target area (e.g., an IO space withinbone or cerebrospinal fluid within a subject's skull). In the embodimentshown, drill bit 542 also includes core 582 extending the length (alsocharacterizable as the entire length) of drill bit 542, from first end546, beyond second end 550, and to the proximal end of the drill bit. Inother embodiments, however, core 582 can extend less than the length ofdrill bit 542 (e.g., and be exposed to biological material at pointsalong drill bit 542 other than at a tip of drill bit 542). Core 582 canbe disposed inside at least outer surface 574. In the embodiment shown,drill bit 542 also includes insulator 586 (e.g., comprising anon-conductive material, such as polytetrafluoroethylene) extending froma location distal of the proximal end of the drill bit (and thus distalof the proximal end of core 582), past second end 550, to first end 546of drill bit 542. Insulator 586 can be disposed at least between core582 and outer surface 574 to prevent electrical communication betweencore 582 and outer surface 574. In some embodiments, insulator 586 has athickness of 0.001 millimeters to 2 millimeters. In other embodiments,insulator 586 can have a thickness of less than 0.001 millimeters ormore than 2 millimeters (e.g., depending on electricity flowing throughcore 582).

In the embodiment shown, outer surface 574, core 582, and insulator 586can be configured to cooperate to form at least one tip 590 at first end546 of drill bit 542. Tip 590 can be configured to penetrate a targetarea (e.g., target area 570) in various ways (e.g., similarly to otherintraosseous devices described and depicted throughout this disclosure(e.g., by having one or more cutting surfaces)). In the embodimentshown, a portion of core 582 is exposed at tip 590 to permit electricalcommunication between tip 590 and a target area. In the embodimentshown, drill bit contact 566 is configured to permit electricalcommunication between controller 522 and at least one of core 582 andouter surface 574. For example, controller 522 can be configured todetermine (e.g., through drill bit contact 566) at least one of current,voltage, impedance, and temperature from outer surface 574 and/or core582.

In the embodiment shown (e.g., depicted in FIGS. 8A, 8D, and 8E), driverassembly 510 (and, more specifically, driver 512) also includes at leastone first electrode 594 (e.g., forming a two-wire configuration withcontroller 522 as depicted in FIG. 8D). First electrode 594 can beplaced (e.g., using an adhesive) in or on a non-target area (e.g.,non-target area 598 comprising biological material, such as skin and/ortissue surrounding bone). Such non-target area may also be near (e.g.,in proximity to) a target area (e.g., target area 570 comprisingbiological material, such as bone and/or bone marrow in the embodimentshown). In some embodiments, the closer the non-target area is to thetarget area, the more effective the driver assembly (and, morespecifically, the driver) will be in determining the desired information(e.g., a voltage difference between core 582 and first electrode 594, animpedance of biological material between core 582 and first electrode594, a change in the voltage difference between core 582 and firstelectrode 594, and/or a change in the impedance of the biologicalmaterial between core 852 and first electrode 594). In otherembodiments, the driver assembly (and, more specifically, the driver)will be more effective in determining the desired information where thenon-target area is farther from the target area (e.g., to minimizevoltage gradients at a target area caused by or resulting from firstelectrode 594). As those of ordinary skill in the art will understand,the anatomy of interest for a procedure will impact the location orposition of first electrode 594 with respect to a target area (e.g., oneskilled in the art may avoid positioning time varying impedanceartifacts (e.g., cardiac activity, respiration, etc.) between core 582and first electrode 594). First electrode 594 is configured to becoupled to controller 522, for example, by patch connector 598. In theembodiment shown, first electrode 594 is coupled (e.g., by a floatingconnection) to an inverting input of a differential amplifier (e.g., andthus coupled to controller 522). Controller 522 can be configured todetermine a voltage difference and/or an impedance between core 582 andfirst electrode 594. Controller 522 can further be configured todetermine a change in a voltage difference and/or a change in impedance(e.g., based on a previous voltage difference and/or impedance, areference voltage difference and/or reference impedance, and the like).In some embodiments, an impedance and/or a voltage difference betweencore 582 and first electrode 594 can be substantially similar to animpedance and/or a voltage difference, respectively, at a target area(depending, for example, on the location of the target area and theposition of core 582). Various other configurations can be used todetermine information about a target area, such as, for example, using adrill bit comprising a split ring electrode core, a three-wireconfiguration, a four-wire configuration, and the like.

In the embodiment shown, driver assembly 510 can further comprise atleast one second electrode 602 coupled to controller 522, such as bypatch connector 598 (e.g., forming at least a three-wire configurationas depicted in FIG. 8E). In the embodiment shown, second electrode 602can be placed (e.g., using an adhesive) in or on a non-target area(e.g., non-target area 606). Second electrode 602 can be placed invarious positions with respect to first electrode 594 and a non-targetarea, such as, for example, concentric with first electrode 594 (e.g.,such that second electrode 602 encircles first electrode 594). In otherembodiments, however, second electrode 602 can comprise various othershapes (e.g., rectangular) and can be placed in various other positionswith respect to first electrode 594 (e.g., parallel to first electrode594). In the embodiment shown, controller 522 can be configured to passa current (e.g., an alternating current (e.g., at 50 KHz)) to secondelectrode 602, meaning the controller is involved in (or plays a rolein) causing a current to pass to the second electrode. In someembodiments, controller 522 can be configured to pass the same currentto core 582 and second electrode 602. For example, controller 522 canpass a current to second electrode 602 having a frequency of 5 kHz to150 kHz. In the embodiment shown, second electrode 602 is involved in(or plays a role in) permitting controller 522 to determine, forexample, a voltage difference between first electrode 594 and core 582,a change in such a voltage difference, an impedance in proximity to (ornear) drill bit 542 and/or a target area (e.g., target area 570), and achange in such an impedance. For example, second electrode 602 canassist in decreasing or minimizing interference (e.g., near fieldeffects) from a non-target area when determining information (e.g., avoltage difference, a change in voltage difference, an impedance, and/ora change in impedance) related to a target area. As those of ordinaryskill in the art will understand, the anatomy of interest for aprocedure will impact the location or position of first electrode 594and/or second electrode 602 relative to the location or position of atarget area and/or a non-target area.

Controller 522 can be configured to determine information about a targetarea (e.g., a target area in biological material) in a variety of ways.In the embodiment shown, controller 522 is configured to determine achange in an impedance and/or a change in a voltage difference (e.g.,between a target area and a non-target area) by, at least in part,reference to a point within the target area, an impedance, and/or avoltage difference. For example, driver 510 comprises reference button607 coupled to controller 522. Reference button 607 is configured to set(e.g., when a user engages reference button 607) a reference point(e.g., marking a physical position within a target area), a referenceimpedance (e.g., marking an impedance at a point within a target area),and/or a reference voltage difference (e.g., marking a voltagedifference (e.g., between a target area and a non-target area) at apoint within a target area). In other embodiments, controller 522 can beconfigured to set a reference point, a reference impedance, and/or areference voltage difference automatically when drill bit 542 contacts apredetermined point (e.g., a bone). If a reference point, a referenceimpedance, and/or a reference voltage difference is set (e.g., by a userengaging reference button 607, automatically, etc.), controller 522 isconfigured to determine a change from the reference point, referenceimpedance, and/or reference voltage difference, respectively. Controller522 can be configured to determine a change in impedance and/or a changein voltage difference by determining an impedance and/or voltagedifference greater or less than the reference impedance and/or thereference voltage difference, respectively. In other embodiments, forexample, controller 522 can be configured to determine a first impedance(e.g., an impedance of bone) and/or a first voltage difference (e.g.,between a target and a non-target area) at a first depth within thetarget area and also determine a second impedance (e.g., an impedance ofbone marrow) and/or a second voltage difference at a second depth withinthe target area. Controller 522 can also be configured to determine achange in impedance and/or a change in voltage difference between thefirst impedance and/or the first voltage difference and the secondimpedance and/or the second voltage difference, respectively. In otherembodiments, controller 522 can be configured to determine a plurality(e.g., two or more) of impedances and/or voltage differencescorresponding to a plurality of depths within a target area. Controller522 can then be configured to determine a change in impedance and/or achange in voltage difference between the plurality of impedances and/orvoltage differences, respectively.

In the embodiment shown, controller 522 can be configured to displayinformation relating to a target area to a user. Driver assembly 510(and, more specifically, driver 512) can comprise display 608 (e.g., oneor more light emitting diodes, a liquid crystal display, and/or noiseindicators) configured to be coupled to controller 522 and configured todisplay information relating to at least one of an impedance, a changein an impedance, a voltage difference, and/or a change in a voltagedifference. In the embodiment shown, display 608 comprises a pluralityof light emitting diodes. In some embodiments, display 608 can beconfigured to display additional information, such as, for example, aposition of a drill bit within a target area, or a depth of a drill bitwithin a target area (e.g., based on an impedance, a change in animpedance, a voltage difference, and/or a change in a voltagedifference).

In the embodiment shown, controller 522 includes various componentsconfigured to permit controller 522 to determine information relating toa target area, display such information, and control a motor. Forexample, in the embodiment shown, controller 522 comprises currentsource 610 configured to produce a current to pass to second electrode602 and core 582 of drill bit 542. In the embodiment shown, currentsource 610 is configured to produce and/or pass a current (e.g., 100 uAto 10 mA) having a frequency of 5 kHz to 150 kHz. In other embodiments,current source 610 can be configured to produce and/or pass a currenthaving a frequency of less than 5 kHz and greater than 150 kHz(depending, for example, on a location of a given target area,resistance in controller 522, resistance in core 582, and resistance insecond electrode 602).

In the embodiment shown, controller 522 also includes oscillator 614configured to produce a signal in the current produced by current source610, such as, for example, an alternating current. For example, in theembodiment shown, oscillator 614 can produce a signal having a frequencyof 5 kHz to 150 kHz. In other embodiments, oscillator 614 can beconfigured to produce a signal having a frequency of less than 10 kHzand greater than 100 kHz (depending, for example, on a location of agiven target area, resistance in controller 522, resistance in core 582,and resistance in first electrode 594).

In the embodiment shown, controller 522 also includes differentialamplifier 618, which can be, for example, a high common mode rejectiondifferential input amplifier. Differential amplifier 618 can be coupledto (e.g., electrically) and configured to receive a voltage from core582 of drill bit 542. Differential amplifier 618 can also be coupled to(e.g., electrically) and configured to receive a voltage from firstelectrode 594. In the embodiment shown, differential amplifier 618 isconfigured to output a voltage difference between core 582 and firstelectrode 594 while a current is applied to second electrode 602 andcore 582. The output from differential amplifier 618 is a function ofand/or correspond to, for example, an impedance at (or near) a targetarea (e.g., biological material in proximity to (or near) drill bit542). Core 582 and first electrode 594 can be coupled to the inputs ofdifferential amplifier 618 in any configuration (e.g., based on adesired signal phase for the output).

In the embodiment shown, controller 522 also includes multiplier 622,which can be coupled (e.g., electrically) to oscillator 614 anddifferential amplifier 618. In the embodiment shown, multiplier 622 isconfigured to multiply a signal from differential amplifier 618 with asignal from oscillator 614 to down convert the voltage output fromdifferential amplifier 618 to produce a baseband frequency (e.g.,similarly to a lock-in amplifier). In the embodiment shown, multiplier618 can produce a direct voltage as a function of and/or thatcorresponds to an impedance at (or near) a target area.

In the embodiment shown, controller 522 also comprises gain amplifier626, which can be coupled (e.g., electrically) to multiplier 618. In theembodiment shown, gain amplifier 626 is configured to increase a voltageof a baseband frequency produced by multiplier 622. For example, gainamplifier 626 can increase the voltage by a factor of 1000. In otherembodiments, gain amplifier 626 can increase the voltage by a factor of100 to 10,000 depending, for example, on a location of a given targetarea and/or resistance in controller 522.

A required system gain can be, for example, optionally distributedbetween differential amplifier 618 and gain amplifier 626.

In the embodiment shown, controller 522 also includes low pass filter630, which can be coupled (e.g., electrically) to gain amplifier 626.Low pass filter 630 is configured to receive a signal from gainamplifier 626 and attenuate a signal having a higher frequency than apredetermined cutoff frequency.

In the embodiment shown, driver assembly 510 (and, more specifically,driver 512) is configured such that display 608 notifies a user if achange in an impedance and/or a change in a voltage difference meets orexceeds a threshold (e.g., a predetermined threshold, which can bepositive or negative, and the exceeding of a negative threshold can be anegative value that is more negative than the negative threshold).Controller 522 includes threshold detector 634 coupled (e.g.,electrically) to low pass filter 630. Threshold detector 634 has apredetermined threshold (such as, for example, one that corresponds to avoltage difference, an impedance, or a current). In some embodiments,the predetermined threshold is adjustable, such that a user can set thethreshold. In other embodiments, driver assembly 510 can permit a userto select from pre-programmed thresholds that, for example, correspondto various target areas (e.g., cranium, sternum, and the like). Low passfilter 630 can output a signal, and if the signal meets or exceeds apredetermined threshold of threshold detector 634, controller 522 cancause display 608 to indicate, for example, at least one of animpedance, a change in an impedance, a voltage difference, a change in avoltage difference, a position of drill bit 542 within a target area,and any other relevant information related to impedance, voltage, and/orlocation of drill bit 542 within a target area.

In the embodiment shown, driver assembly 510 (and, more specifically,driver 512) also includes motor controller 638. Controller 522 isconfigured to permit motor controller 638 to deactivate (and/oractivate, in some embodiments) motor 526 if a change in an impedanceand/or a change in a voltage difference meets or exceeds a predeterminedthreshold. In other embodiments, controller 522 can be configured topermit motor controller 638 to change (e.g., increase and/or decrease) arotational speed of motor 526 (e.g., and indirectly drill bit 542) if achange in an impedance and/or a change in a voltage difference meets orexceeds a predetermined threshold.

The present drill bits, drivers, and driver assemblies may be used, forexample, in any procedure in which it is desirable to identify (whetherautomatically or through a notification that can be recognized by auser) a change in the biological material through which an IO device(such as a drill bit or a needle set) is advancing. A craniotomy is oneexample of such a procedure. Another example is the placement of aneedle set in an IO space within the sternum. Some embodiments of thepresent methods of determining an impedance, a change in an impedance, avoltage difference, and/or a change in a voltage difference relating toa target area and/or a non-target area with an embodiment of the presentdriver assemblies comprise placing a first electrode (e.g., firstelectrode 594) of a driver assembly (e.g., driver assembly 510) in or ona non-target area (e.g., non-target area 606), moving a drill bit (e.g.,drill bit 542) of the driver assembly through biological material (e.g.,skin and tissue) toward a target area (e.g., target area 570, such asbone marrow or a location inside the skull (such as a location occupiedby cerebrospinal fluid)) in biological material, and determining atleast one of an impedance (e.g., at or near a target area), a change inan impedance, a voltage difference (e.g., between a target area and anon-target area), and a change in a voltage difference. In someembodiments, the method can further comprise placing a second electrode(e.g., second electrode 602) in or on the non-target area (e.g., formingat least a three-wire configuration to minimize or decrease near fieldeffects of a non-target area). Further, the method can comprisedisplaying a notification when at least one of the impedance, the changein an impedance, the voltage difference, and/or the change in a voltagedifference meets or exceeds a threshold. As another example, the methodcan comprise changing and/or stopping a rotational velocity of the drillbit when at least one of the impedance, the change in an impedance, thevoltage difference, and/or the change in a voltage difference meets orexceeds a threshold. The method can further comprise removing the drillbit from the target area, such as to permit access to the target area.

A method of determining an impedance, a change in an impedance, avoltage difference, and/or a change in a voltage difference with anembodiment of the present driver assemblies can comprise, for example,placing a first electrode (e.g., first electrode 594) of a driverassembly (e.g., driver assembly 510) in or on a non-target area (e.g.,non-target area 606), moving a drill bit (e.g., drill bit 542) of thedriver assembly through biological material toward a target area (e.g.,target area 570) in biological material, setting at least one of areference impedance and a reference voltage difference, and determininga change from at least one of the reference impedance and the referencevoltage difference such as in a manner described above. In someembodiments, the method can further comprise placing a second electrode(e.g., second electrode 602) in or on the non-target area (e.g., to format least a three-wire configuration to minimize or decrease near fieldeffects of a non-target area). Further, the method can comprisedisplaying a notification when at least one of the impedance, the changein an impedance, the voltage difference, and/or the change in a voltagedifference meets or exceeds a threshold. As another example, the methodcan comprise changing and/or stopping a rotational velocity of the drillbit when at least one of the impedance, the change in an impedance, thevoltage difference, and/or the change in a voltage difference meets orexceeds a threshold. The method can also comprise removing the drill bitfrom the target area, such as to permit access to the target area.

Similarly to other embodiments of intraosseous devices (or components ofintraosseous devices) described in this disclosure, embodiments of thepresent drivers, driver assemblies, and drill bits (and components ofsuch embodiments) can also be included in one or more kits. A kitcomprising one or more embodiments (or one or more components) of thepresent driver assemblies can comprise one or more IO devices (or one ormore components of IO devices) of any of the kits described in thisdisclosure (e.g., as depicted in FIG. 7A-7C). For example, a kit cancomprise a driver (e.g., driver 510) and an intraosseous deviceconfigured to be coupled to the driver (e.g., drill bit 542). In someembodiments, a kit can also comprise at least one of a cannula and astylet. In some embodiments, a kit can further comprise a couplerconfigured to couple the driver to the intraosseous needle set. In otherembodiments, the kit can comprise an aspiration device configured to becoupled to a cannula. In some embodiments, a kit can comprise at leastone sharps protector configured such that at least one of the cannula,the stylet, and the drill bit can be disposed in the sharps protector toprevent exposure of a cutting surface. In other embodiments, a kit cancomprise a containment assembly configured to seal the driver inside thecontainment assembly to prevent desterilization of at least one of theintraosseous needle set and a target area.

The above specification and examples provide a complete description ofthe structure and use of exemplary embodiments. Although certainembodiments have been described above with a certain degree ofparticularity, or with reference to one or more individual embodiments,those skilled in the art could make numerous alterations to thedisclosed embodiments without departing from the scope of thisinvention. As such, the various illustrative embodiments of the presentdevices are not intended to be limited to the particular formsdisclosed. Rather, they include all modifications and alternativesfalling within the scope of the claims, and embodiments other than theone shown may include some or all of the features of the depictedembodiment. For example, components may be combined as a unitarystructure and/or connections may be substituted. Further, whereappropriate, aspects of any of the examples described above may becombined with aspects of any of the other examples described to formfurther examples having comparable or different properties andaddressing the same or different problems. Similarly, it will beunderstood that the benefits and advantages described above may relateto one embodiment or may relate to several embodiments.

The claims are not intended to include, and should not be interpreted toinclude, means-plus- or step-plus-function limitations, unless such alimitation is explicitly recited in a given claim using the phrase(s)“means for” or “step for,” respectively.

1. A driver assembly configured to determine information about a targetarea, the driver assembly comprising: a driver comprising: a controller;a motor coupled to a power source and further coupled to the controller;and a first electrode configured to be coupled to the controller andfurther configured to be placed in or on a non-target area; where thecontroller is configured to activate and/or deactivate the motor; and adrill bit configured to be coupled to the driver and further configuredto penetrate the target area, the drill bit comprising: a distal portionhaving a first end, a second end, and an outer surface extending fromthe second end to the first end of the distal portion of the drill bit;the drill bit configured to be coupled to the controller by anelectrical connection to permit electrical communication between thedrill bit and the controller; and where the driver assembly isconfigured to determine a voltage and/or a voltage difference betweenthe target area and the non-target area, an impedance at the targetarea, and/or a change in at least one of a voltage difference and/or animpedance.
 2. The driver assembly according to claim 1, furthercomprising a drill bit coupler including a first end configured to becoupled to the second end of the drill bit, and a second end configuredto be coupled to the driver.
 3. The driver assembly according to claim2, wherein the drill bit coupler comprises an insulator configured toprevent heat and/or electricity from the drill bit from passing beyondthe drill bit coupler.
 4. The driver assembly according to claim 1,wherein the driver further includes a drill bit contact coupled to thedrill bit and the controller, the drill bit contact configured toprovide a commutating electrical connection between the drill bit andthe controller.
 5. The driver assembly according to claim 4, wherein thedrill bit contact comprises a non-conductive coating configured toprevent electricity from the drill bit from passing beyond the drill bitcontact.
 6. The driver assembly according to claim 1, wherein the outersurface of the distal portion of the drill bit includes groovesconfigured to enable the drill bit to penetrate bone to reach anintraosseous space.
 7. The driver assembly according to claim 1, whereinthe drill bit further includes a core extending along a length of thedrill bit.
 8. The driver assembly according to claim 7, wherein the coreextends from the first end of the drill bit, beyond the second of thedrill bit, and to a proximal end of the drill bit.
 9. The driverassembly according to claim 8, wherein the drill bit includes aninsulator extending from a location distal of the proximal end of thedrill bit and distal of a proximal end of the core, past the second endof the drill bit, to the first end of the drill bit.
 10. The driverassembly according to claim 9, wherein the insulator is disposed betweenthe core and the outer surface to prevent electrical communicationbetween the core and the outer surface.
 11. A method comprising: placinga first electrode of a driver assembly in or on a non-target area;moving a drill bit of the driver assembly through biological materialtoward a target area in biological material; determining at least one ofan impedance, a change in an impedance, a voltage difference, and achange in a voltage difference; and changing or stopping a rotationalvelocity of the drill bit when at least one of the impedance, the changein an impedance, the voltage, and the change in a voltage differencemeets or exceeds a threshold.
 12. The method of claim 11, furthercomprising: displaying a notification when at least one of theimpedance, the change in an impedance, the voltage, and the change in avoltage difference meets or exceeds a threshold.
 13. The method of claim11, further comprising: placing a second electrode in or on thenon-target area to form at least a three-wire configuration with thedrill bit and the first electrode.
 14. The method of claim 11, furthercomprising: removing the drill bit from the target area to permit accessto the target area.
 15. The method of claim 11, wherein the drill bitassembly further comprises a drill bit coupler configured to couple thedrill bit to the driver.
 16. A method of determining at least one of achange in an impedance and a change in a voltage difference acrossbiological material, the method comprising: placing a first electrode ofa driver assembly in or on a non-target area; moving a drill bit of thedriver assembly through biological material toward a target area inbiological material; setting at least one of a reference impedance and areference voltage difference; determining a change from at least one ofthe reference impedance and the reference voltage difference; andchanging or stopping a rotational velocity of the drill bit when thechange from at least one of the reference impedance and the referencevoltage difference meets or exceeds a threshold.
 17. The method of claim16, further comprising: displaying a notification when the change fromat least one of the reference impedance and the reference voltagedifference meets or exceeds a threshold.
 18. The method of claim 16,further comprising: placing a second electrode in or on the non-targetarea to form at least a three-wire configuration.
 19. The method ofclaim 16, further comprising: removing the drill bit from the targetarea to permit access to the target area.
 20. The method of claim 16,wherein the drill bit assembly further comprises a drill bit couplerconfigured to couple the drill bit to the driver.